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Recruiting NCT06156865

Using Neuroimaging and Behavioral Assessments to Understand Late Talking

No phase Interventional Developmental Language Disorder Language Delay Language Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention to address late talking.
Who it may be relevant to
Registry conditions: Developmental Language Disorder, Language Delay, Language Development. Basic parameters: 18 months — 30 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neuroimaging Reveals Treatment-related Changes in DLD: A Randomized Controlled Trial (Supplement)

Overview

Late talkers (LT), representing 10-20% of children under 3, demonstrate hallmark syntax and vocabulary deficits similar to preschoolers with developmental language disorder. While effective and early interventions can mitigate the impact of late talking, not enough is known about its neural basis, yet is needed to inform the design of more individualized interventions. This proposed effort uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie learning and late talking, while also considering their association to treatment-related changes in LT.

Detailed description

Late talking represents one of the most common reasons children under 3-years of age are referred for speech-language evaluations, impacting about 10%-20% of children in this age-group. Late talkers (LT) also share similarities with children diagnosed with developmental language disorder (DLD) at 4 - 5 years of age, endorsing the notion that shared neurobiological underpinnings might exist between these two clinical groups. However, little is known about the neural basis of late talking, yet is needed to better inform the design of efficacious therapies that address hallmark delays in syntax and vocabulary. For the DLD population, domain-general processes relating memory and language are being investigated in the parent grant, offering valuable testing ground for also advancing the current knowledge base regarding LT. The Procedural circuit Deficit Hypothesis (PDH) posits that relative strengths and weaknesses exist between procedural (impaired) and declarative (less impaired) memory systems. Structural abnormalities in connections between frontal brain regions and basal ganglia, with under activation and reduced connectivity also evident. However, cortical and subcortical regions in the temporal lobes, including hippocampus, might be impaired to a lesser degree.

This proposed research will use diffusion imaging to describe the neural basis (structural connectivity) of late talking and treatment-related change by way of the PDH. The investigators will gather data regarding LT before, after, and following a break in standard intervention for LT (e.g., parent coaching, direct therapy for children who are LT): LT treatment. The investigators will also include a "business as usual": LT no treatment as part of a highly feasible pragmatic design that leverages existing pipelines. The investigators will also include typically developing (TD) peers to inform development vs late talking. The central hypothesis is that treatment designed to improve syntax and vocabulary will change procedural and declarative networks in association with increases in language function and the degree of improvement may be associated with the underlying neurobiology of baseline syntax and vocabulary deficits.

Building on a robust history of recruitment and treatment of toddlers by the investigators' partnering sites, and the investigators' successful imaging partner, this project will enroll 30 LT (n=15 treatment; n=15 controls) and 15 TD peers. Aim 1 will establish the structural connectivity in LT and their TD peers between regions in the procedural learning and declarative networks. In Aim 2, the investigators will establish the neurobiological basis of treatment-related changes in LT only. The investigators examine potential changes in structural connectivity between regions of the procedural learning and declarative memory networks, and investigate whether treatment-related changes occur into the typical range (LT, TD). To meet the scientific goals, the investigators pair behavioral tools (syntax and vocabulary) with neuroimaging to describe co-occurring behavioral performance underlying learning and outcome, while also gathering parental and clinician qualitative data regarding treatment outcomes. This research will contribute novel insights into mechanisms underlying learning and impairment to offer a ground-breaking shift in the understanding of LT.

Interventions

  • Behavioral Intervention to address late talking
    this intervention is designed to support both speech and language development in children who are toddlers. Given the age group of children their parents are part of the intervention program. Importantly the frequency of the intervention can range from once to twice per week, with timing also designed to complement the particular agency

Primary outcome measures

  • Aim 1/Pre - Structural connectivity data using diffusion imaging [Time frame: Weeks 1 to 2 (Time 1/pre)]
  • Aim 2/Pre - Changes in structural connectivity data using diffusion imaging [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
Secondary outcome measures (12)
  • Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set) [Time frame: Weeks 1 to 2 (Time 1/pre - first set)]
  • Aim 1 - Raw score on the Focus on the Outcomes of Communication Under Six Parent Version- (second set) [Time frame: Weeks 1 to 2 - (Time 1/pre - second set)]
  • Aim 1/Pre - Raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set) [Time frame: Weeks 1 to 2 - (Time 1/pre - third set)]
  • Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set) [Time frame: Weeks 1 to 2 - (Time 1/pre - fourth set)]
  • Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set) [Time frame: Weeks 1 to 2 - (Time 1/pre - fifth set)]
  • Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set) [Time frame: Weeks 1 to 2 - (Time 1/pre - sixth set)]
  • Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set) [Time frame: Weeks 1 to 2 - (Time 1/pre - seventh set)]
  • Aim 2 - Changes in structural connectivity data using diffusion imaging for late talkers only [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set) [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Parent Version- (second set) [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set) [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Intelligibility in Context Scale- (fourth set) [Time frame: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]

Eligibility criteria

Inclusion criteria

  • child and parent are monolingual/native (primarily) English speakers
  • child is enrolled at one of the participating facilities
  • child is recruited via word of mouth, including social media
  • child is between 18 and 30 months of age
  • child does not have any contraindications to magnetic resonance imaging (i.e., intracranial metal implants, claustrophobia)
  • child does not have any uncorrected vision challenges

Exclusion criteria

  • Child does not meet criteria for LT or typical development
  • Standard magnetic resonance imaging exclusion criteria
  • Gestational age less than 37 weeks or greater than 42 weeks
  • Special education placement of child based on ability or behavior

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Grandview Kids — Oshawa
  • Speech Specialists — Toronto

Identifiers

NCT: NCT06156865 · 3R01DC019337-04S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗